Quality Assurance
Every Vial. Verified.
Independent lab testing, lot-level traceability, and documented release criteria on every product we ship — before it ever reaches your clinic.
✓ FDA-Registered Facility
✓ cGTP Compliant — 21 CFR Part 1271
✓ NTA-Verified Particle Count
Our Commitment
Why Documentation Matters in Regenerative Biologics
In a market where many suppliers advertise particle counts without verification, potency claims without testing, and compliance language without documentation — Stem Nova Network takes a different position. Every product we supply comes with real lot-level test data, not marketing language. This page documents exactly what we test, how we test it, and what the results look like.
Manufacturing credentials ≠ product approval.
The testing documentation, AATB accreditation, FDA-registered facility status, and cGTP-compliant manufacturing described on this page are manufacturing quality and facility credentials. They do not constitute FDA approval of any Stem Nova Network product for any therapeutic indication. These products are not FDA-approved drugs or therapeutic agents.
01
Lot-Level Testing
Every batch is assigned a unique lot number with full test documentation. When you order, you can trace exactly which lot your product came from and what its test results were.
02
Independent Verification
Testing is performed both in-house and through a qualified independent third-party laboratory. Both results must meet release criteria before a lot ships.
03
Verified Particle Counts
Exosome particle counts are verified via NTA (Nanoparticle Tracking Analysis) using ZetaView instrumentation — not estimated, not extrapolated. Concentration, size distribution, and total count are all documented per lot.
04
Release Criteria Required
Products do not ship unless all release criteria are met. Failed lots are quarantined and never distributed. This is not an optional step — it is a hard gate in our manufacturing process.
3DExo+™ Matrix — Lot 3D-A1-2410-D
Exosome Release Testing Results
Sample Certificate of Analysis data from our 60 Billion Exosome Matrix. Each lot shipped carries equivalent documentation with lot-specific results.
Particle Concentration (NTA)
ZetaView NTA Size Distribution
📄 Certificates of Analysis Available Upon Request — Enrolled clinic partners can request the full COA for any lot received. Contact info@stemnovanetwork.com with your lot number.
hUCT-MSC — Lot MHXX10
Stem Cell Release Testing Results
Full release panel for our 25 Million hUCT-MSC product. All assays must pass before lot release.
Direct inoculation per 21 CFR 610.12
🔬 Donor Eligibility Per FDA 21 CFR Part 1271 — All tissue donors meet full eligibility and testing requirements for birth tissue under FDA 21 CFR Part 1271.
Viral Screening Panel
Pathogen Testing — All Negative
Each lot of hUCT-MSC product is screened for the following pathogens prior to release. All results must return negative before the lot is approved for distribution.
✓ Adventitious — Not Detected
Regulatory Documentation
Facility Credentials & Regulatory Standing
📋 What Our Credentials Mean for Your Practice
Sourced from an AATB-Accredited, FDA-Registered Tissue Establishment
Stem Nova Network products are sourced from an AATB-accredited, FDA-registered tissue establishment operating under current Good Tissue Practice (cGTP) standards per 21 CFR Part 1271 — licensed in all applicable states requiring tissue facility certification, including compliance with Florida HB 1768.
These facility and manufacturing credentials do not constitute FDA approval of any product for any therapeutic indication. Practitioners should not represent these credentials to patients as product approval.
Accreditation
AATB Accredited
American Association of Tissue Banks — recognized quality benchmark for tissue establishments. Named in Florida HB 1768 as an acceptable accrediting body.
FDA Registration
FDA-Registered Facility
Registered with the FDA as a human cell, tissue, and cellular and tissue-based product (HCT/P) establishment per 21 CFR Part 1271.
Manufacturing Standard
cGTP Compliant — 21 CFR Part 1271
Current Good Tissue Practice — the correct governing standard for HCT/P tissue products. Documented SOPs, environmental monitoring, and batch records.
Sterility
21 CFR 610.12
Direct inoculation — the regulatory standard for biological products.
Tissue Sourcing
FDA 21 CFR Part 1271
Full donor eligibility requirements for human cells and tissue products.
Particle Analysis
NTA — ZetaView
Verified particle count, mean size, and size distribution per lot.
Source Material
Where Our Biologics Come From
UCT-MSC Source — Wharton's Jelly
✓ Derived from first-pregnancy umbilical cord tissue (Wharton's Jelly)
✓ Biologically younger than adult or adipose-derived MSCs
✓ Naturally immune-privileged — low MHC expression
✓ Free from environmental damage present in adult tissue sources
✓ Ethically donated from screened, consenting donors
✓ Country of origin: USA
3D Bioreactor Culturing System
✓ Hollow-fibre 3D bioreactor systems — mimics native tissue
✓ Up to 19.4× more exosomes vs conventional 2D culture
✓ 15.5× higher exosome concentrations vs standard 2D methods
✓ 100% xeno-free — no animal serum, no FBS contamination
✓ Richer secretome: exosomes, cytokines, growth factors, microRNA
✓ Consistent lot-to-lot output via controlled bioreactor parameters
Our Products
Shop Verified Biologics
All products listed below carry the testing standards documented on this page. Enroll your clinic to access wholesale pricing and lot-specific COA documentation.
Exosome Matrix
3DExo+™ Matrix — 60B Exosomes
Topical cosmetic biologic · 1mL · NTA-verified particle count
View Product →
Dermal Exosomes
Dermal Papillary Secretome — 150B
Topical cosmetic biologic · 1.8mL · Dual-lab COA verified
View Product →
Stem Cells
hUCT-MSC Stem Cells — 25M
Cryo-packed · 97% viability · Wharton's Jelly source
View Product →
Ready to Enroll Your Clinic?
Access Wholesale Pricing & Lot-Specific COAs
Licensed medical professionals, medspas, and regenerative clinics nationwide.
For professional, educational, and research use by licensed providers only. Products supplied by Stem Nova Network are not FDA-approved and are not intended to diagnose, treat, cure, or prevent any disease. All clinical applications are determined at the discretion of the licensed provider within their applicable scope of practice and state regulations. Testing data shown represents sample lot results; actual lot-specific documentation available upon request.
